Fractional Laser Treatment of Vulvovaginal Atrophy and U.S. Food and Drug Administration Clearance

Fractional Laser Treatment of Vulvovaginal Atrophy and U.S. Food and Drug Administration Clearance

Position Statement
The American College of Obstetricians and Gynecologists and
The American Congress of Obstetricians and Gynecologists
Several media outlets have described fractional carbon dioxide (CO2) laser as
“approved” or “cleared” by the U.S. Food and Drug Administration (FDA) for the
treatment of vulvovaginal atrophy (http://www.medicaldaily.com/fda-approves-monalisa-
touch-laser-vaginal-dryness-caused-vaginal-atrophy-313184,
http://www.realself.com/question/seattle-wa-the-monalisa-touch- and-work, and
http://blogs.webmd.com/womens-health/2015/07/how-to-treat-vaginal-dryness-inmenopause.
html). The purpose of this Position Statement is to advise obstetrician–
gynecologists and patients that this technology is, in fact, neither approved nor cleared
by the FDA for the specific indication of treating vulvovaginal atrophy.
Under its 510(k) process, the FDA has cleared a fractional CO2 laser (DEKA SmartXide2
CO2 laser) for the indications of “incision, excision, ablation, vaporization, and
coagulation of body soft tissues in medical specialties, including aesthetic (dermatology
and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery,
orthopaedics, general and thorasic surgery (including open and endoscopic), dental and
oral surgery and genitourinary surgery”1. In addition, another laser system (Cynosure,
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1U.S. Food and Drug Administration. Re: trade/device name: DEKA SmartXide2 Laser
System [letter]. Silver Spring (MD): FDA; 2014. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf13/k133895.pdf. Retrieved May 19, 2016.
The American College of Obstetricians and Gynecologists
The American Congress of Obstetricians and Gynecologists
409 12th Street, SW • PO Box 96920 • Washington, DC 20090-6920 • Telephone 202-638-5577
Fractional Laser Treatment of Vulvovaginal Atrophy and
U.S. Food and Drug Administration Clearance
Page 2
Inc., RevLite Q-Switched Nd: YAG Laser System) has been cleared by the FDA for
“incision, excision, ablation, vaporization of soft tissue for General Dermatology,
Dermatologic and General Surgical procedures for coagulation and hemostasis” 2. It is
important to note that although there are a number of indications enumerated for this
technology, the specific indication for the treatment of vulvovaginal atrophy is not listed.
Preliminary observational data have shown some potential benefits with the use of this
technology in treating patients with vulvovaginal atrophy 3–5. However, these
observational trials do not evaluate the use of concomitant treatments, and they lack
long-term follow-up (trials assessed follow-up at 12 weeks). No randomized trials or
comparative effectiveness studies have been published
(www.medscape.com/viewarticle/846960). Although initial data indicate potential utility,
additional data clearly are needed to further assess the efficacy and safety of this
procedure in treating vulvovaginal atrophy, particularly for long-term benefit.
Obstetrician–gynecologists should be cognizant of the evidence regarding innovative
practices, and should be wary of adopting new or innovative approaches on the basis of
promotions or marketing 6. It is critical that patients are provided with accurate
information regarding the efficacy and safety of treatment options, particularly when
considering emerging technology. One component of this information is an accurate
description of the FDA’s clearance or approval terminology. Obstetrician–gynecologists
have an ethical responsibility to provide accurate and current information to patients in
order for them to be fully engaged in the informed decision-making process.
Approved by the Executive Board: May 2016
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2 U.S. Food and Drug Administration. Re: trade/device name: RevLife Q-Switched
Nd:YAG Laser System [letter]. Silver Spring (MD): FDA; 2014. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf13/k133254.pdf. Retrieved May 19, 2016.
3 Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, et al. Sexual
function after fractional microablative CO(2) laser in women with vulvovaginal atrophy.
Climacteric 2015;18:219–25.
4 Salvatore S, Nappi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, et al. A 12-week
treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric
2014;17:363–9.
5 Stefano S, Stavros A, Massimo C. The use of pulsed CO2 lasers for the treatment of
vulvovaginal atrophy. Curr Opin Obstet Gynecol 2015;27:504–8.
6 Innovative practice: ethical guidelines. ACOG Committee Opinion No. 352. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2006;108:1589–95.